Well, looks like SHPG will finish additional trials in H1/14.
So, if those trials show that Midodrine is effective, then that would be bad news for CHTP and their alternative drug Northera. I suppose that since SHPG is the one doing the Midodrine trials, they will be ideally positioned to could decide whether or not a buyout of CHTP makes sense.
@@@@Shire is the NDA holder for midodrine HCl, which had been marketed by Shire until 2010 under the brand name ProAmatine®. Shire has no financial interest in midodrine, and no longer manufactures, distributes or markets the brand name version of midodrine HCI, ProAmatine. Beginning in 2003, midodrine has been manufactured and distributed by generic pharmaceutical companies. As the NDA holder, Shire has continued to invest in the needed regulatory processes and has worked diligently with the FDA to develop this now agreed path forward that may permit midodrine to maintain its marketing authorization thus allowing it to remain available for patients who critically need this medicine. “Even though Shire no longer generates revenue from midodrine, we’ve agreed to invest more time and resources in additional clinical trials because we know it’s the right thing to do for patients,” added Jonas. “Preliminary work on these two midodrine trials is underway and we anticipate completion in the first half of 2014.”
Market waiting on CHTPS recently approved Northera. It will be a money maker for the lucky company that buys CHTP in my humble opinion.
Even comforting news from GS doesn't seem to be able to set this stock back on track... In any case, this is a core holding for me so it's still nice to hear.
Goldman Comments on Shire's (SHPG) Lialda Appeals Court Decision
8:45 AM ET, 03/31/2014 - Street Insider
Goldman Sachs maintained a Conviction Buy rating on Shire (NASDAQ: SHPG). Analyst Keyur Parekh commented on Lialda litigation.
"We believe there is significant confusion on what Friday's (March 28) decision from the US Court of Appeals means for Lialda's continued US exclusivity. Based on our conversations with Shire and Actavis as well as historical timelines, we believe a generic Lialda in the US market pre 2016 appears unlikely," said Parekh.
"We continue to see Lialda as a growth driver for Shire and believe impact from any potential generic competition is likely to be modest. In addition, our previous analysis suggests that Shire has enough cost cushion to largely offset any Lialda-related impact on the bottom line," he added.
Deutsche Bank Comments on Shire (SHPG) Lialda Litigation
1:26 PM ET, 03/28/2014 - Street Insider
Deutsche Bank analyst Mark Clark commented on Shire (NASDAQ: SHPG) Lialda litigation. Shares traded lower after appeal Court sent litigation back for further proceedings.
"Watson/Actavis appealed this ruling and a Federal Appeals Court has today reversed the ruling, having disagreed with some of the patent claim definitions ( constructions ) agreed in the District Court, and remanded the case for further proceedings , ie, sent it back to District Court to be heard afresh. Crucially the Appeal Court does not overturn the original decision in favour of the validity of the 720 patent. Thus the further litigation will be decided on whether Watson/Actavis infringe the patent," said Clark.
"The '720 patent on Lialda runs to June 2020 and unless generic challengers are shown to (a) not infringe the patent and (b) meet FDA bioequivalence standards (see below) then Lialda will not face generics before its patent expiry. The fact Watson/Actavis can now litigate afresh does not necessarily mean they will win the next round, merely that the Appeal Court disagreed with some of the definitions used in the District Court case. Additionally, during the course of the District Court trial, data was disclosed on Watson/Actavis putative generic which Shire believes would not meet FDA bioequivalence guidelines. Thus it is Shire s belief (and it claims that of independent experts) that, even if Watson/Actavis is ultimately determined not to infringe its patent, the FDA will not be in a position to approve its generic. The three other generic challengers (Zydus Cadila, Mylan, Osmotica) each have different formulations of their putative generics and thus will separately have to go through non-infringement litigation and FDA review," he added.
Deutsche Bank has a Buy rating on Shire (NASDAQ: SHPG)
Big drop... from 153 to 146 in a few minutes on high volume... now recovering back up to 151.
I don't see any news out. Is this all related to technicals? On the LSE chart the 20day SMA is set to cross down through the 50day line, and the stock price is right at the 100day support. On the US markets, an order of 50 put contracts April expiry 150 strike triggered near that 146 low. Weird, really weird
No idea sorry... but I think SHPG does not generate any revenue off this anyway so what does it matter?
SGMO up 20% this morning based on success of genomic program in HIV. SGPG has exclusive partnership to utilize SGMO's gene Rx in hemophilia, etc. Looking like a wise partnership move by Shire
Sold the calls on the brief recovery from that huge drop this morning. Was planning to roll out the calls to Oct expiry but decided to sit and wait out the action today... glad I did.
Been watching the SHPG options and see some activity on the 180 strike calls exp Jul2014... looks like buying since it's close to the ask (along with some selling at the 190/195 strikes). Damm I wish there were LEAP's available on this ticker.
I went longer yesterday. Now levered with some July calls and my core stock holding. Dam I wish LEAPS were available for this stock.
All systems go for 2014
@@@@British drugmaker Shire (SHPG) beat Wall Street's Q4 estimates Thursday morning and said its CFO will step down. Its shares were up nearly 1% in early trading in the stock market today, near 157 and hitting an all-time high for the sixth day in the past seven trading sessions.Shire's profit rose 36% over the year-earlier quarter to $2.26 a share, beating consensus by 24 cents. Sales rose 12% to $1.33 billion, topping analysts' $1.28 billion. The company said 2014 sales growth should be in the mid- to high teens (current consensus is 17%) and that earnings growth should be similar to last year's 23%, implying upside on analysts' estimate of $9.14 a share.
so no bonus application for this ADHD drug... oh well there's still a chance it'll work for bing eating. Anyway, Mr.Market appears to be taking it all in stride.
@@@@Shire plc (LSE: SHP, NASDAQ: SHPG) announces top-line results from two pivotal Phase 3 investigational studies evaluating the efficacy and safety of Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) versus placebo as an adjunctive treatment for major depressive disorder (MDD) in adults who inadequately responded to antidepressant monotherapy with a SSRI or SNRI. Vyvanse did not meet the primary efficacy endpoint versus placebo for either study. The safety profile for Vyvanse in these two studies appears to be generally consistent with the known profile established in studies in adults with Attention-Deficit/Hyperactivity Disorder (ADHD). Based on these clinical trial results, Shire will no longer pursue this clinical development program. "While this news in major depressive disorder is disappointing for patients and Shire, we will later in the year be filing with the FDA for a new indication for Vyvanse in Binge Eating Disorder in adults, and Vyvanse is an effective and leading treatment for ADHD," said Flemming Ornskov, M.D., Shire's Chief Executive Officer